del-fi • 23andme Gets A Nastygram For The Holidays

"As of today, the FDA has absolutely smacked down 23andme’s attempt to sell spit kits for genotyping as medical devices. I encourage you to read the letter itself, it’s an unusually scathing tone for a rather studiedly gray agency. 23andme has been leveraging a gap in the market for a long time - the idea that their spit kit that creates a file of individual genetic variation is recreational, not a medical device that increases health. Over the past year their rhetoric around health has ratcheted up, and they’ve very loudly engaged with the FDA since the middle of 2012. They were proud of this fact. It set them apart from other DTC companies. Since last year, I for one have been eagerly awaiting the outcomes. Nobody else has the sample size of 23andme. If 400,000 sets of genetic variations are in one place, with smart people studying them, what can come out? It’s the first look at a lot of genotypes at scale, by an agency whose job it is to tease out whether or not there’s a health effect, and if so, if that effect is positive. That’s a big deal. Whatever the answer, that’s a big deal. Somebody got to look into that particular box, and knows the answer. The whole point of the FDA process is that you have to submit the answer for review. But here’s the thing, there’s no answer at all yet. 23andme hasn’t called back…for a while.  If the answer is inconclusive, there’s plenty of money to be made fighting it through the normal process. That’s the bread and butter of the biotechnology industry - fighting the FDA over the fine details of efficacy and safety to get devices and drugs onto the market.  The fact that 23andme basically cut off communications in May - and addressed this warning letter on Facebook, a strategy cut straight from Sarah Palin’s school of crisis management - is a strong sign that the data are at this point conclusive.  But since 23andme won’t tell anyone, we don’t know which way. This fits into a general pattern of espousing open science while not practicing it for the company. So the data are either really bad, and releasing them would forestall the chance to get more people enrolled and wait for Metcalfe’s Law to kick in, or they’re so good that they’re worth picking a public fight with the federal agency least likely to be disrupted by a startup.  And the early messaging, also reported by Fast Company, doesn’t indicate strength - instead, it appears the first line of response is not 'look how awesome our data is' but 'the health insurance companies are terrified of us.' I tend to think that Kaiser could drop the $100 per patient and sequence 5.6% of their enrollees for free, within a year, if they were terrified. I think the data aren’t there yet.  I’m a deep believer that genetics generally, and personal sequencing in particular, will drive a marked and permanent change in health. But 23andme are either theretoday or they aren’t. They dealt the play last summer when they started this process, and advertised it. They’ve upped it by framing themselves as a daring company. But they’re going after the FDA with this strategy. And if you come at the king, you best not miss."